Patent Application
20190183676
The present invention relates to systems, and methods of use, of devices that aid in the delivery of a liquid drop to a region of interest (ROI). For example, the delivery of a drop from a dispenser to an eye can be aided by the use of a device which helps to stabilize the dispenser in the correct position for ensuring successful delivery of a drop of liquid to the eye. The liquid drop delivery devices can also be structured to accommodate single-use containers of liquid. Additionally, the liquid drop delivery devices can be equipped with a feedback system (an optical system, a sensor system, etc.) for collecting and providing feedback data on whether a drop is successfully delivered to the ROI or indicating whether and when the device is being used, or (alternatively or in addition) with a delivery system to assist and/or automate the delivery process.
The successful delivery of liquid from a squeezable container to a pre-determined region of interest (as a non-limiting example, the application of a liquid drop to a non-heterogeneous biological target) can be a difficult task. For example, applying eye drops to the eye is difficult, with many people experiencing difficulty getting each and every drop in the eye. A number of devices have been developed to aid in eye drop delivery, and they each have their own set of issues on drop delivery. For example, those devices that rest on the tissue around the eye make it difficult to hold the eye lid open to insure the drop gets into the eye, and there is a natural tendency to close the eye when it is covered.
Current devices that aid in the application of a liquid drop to a ROI also lack the ability to conform to the specific needs of the user. There is an unfulfilled need for an operational device-based platform that facilitates the successful delivery of liquid drops to the ROI based on the specific need of an individual user, where the need of the individual user may change over time.
An embodiment of the present invention provides a set of devices configured to retain a dispenser of liquid. As used herein, and unless expressly defined otherwise, the terms “set”, “kit”, “array” where applied to devices are intended to define and cover one or more devices. A device in the set includes a base with a top side and a bottom side (the base having first and second base ends); an arm extending from the top side of the base at a first end of the arm; and a holder portion with a bore formed through the holder portion and having a bore axis, the bore sized to removably retain an end of the dispenser. The holder portion is affixed to a second end of the arm to define a target region for drops emitted from a tip of the dispenser (when the dispenser is retained in the bore) in a first plane parallel to a plane that passes through the first and second base ends, the target being substantially centered at the bore axis. The device may optionally contain a unit that includes an optical system with a field-of-view (FOV). Such unit is cooperated with the arm to orient the FOV to cover the tip and the target region (when the dispenser is retained in the bore) to dispense the liquid towards the target region. In one embodiment, the base is arcuately shaped and dimensioned to fit above and in contact with a user's nose bridge; the bore axis passes through an eye of the user when the base is positioned on the user's nose bridge; and/or the bore has a cross-section (in a plane transverse to the bore axis) which is one of (i) a rectangular cross-section and (ii) as a cross-section in which the bore defines a curve having a radius of curvature (in one embodiment—a constant radius of curvature). Alternatively or in addition, at least one of a length of the arm and an inclination of the arm with respect to the base is adjustable to position the bore axis to pass through a user's eye once the base is positioned on a user's nose bridge. The device may further comprise a wing portion affixed to the arm at a point between holding portion and the base and extending from the arm along an axis that is transverse to a reference plane, which reference plane contains the bore axis and passes through the arm. In a specific embodiment, the base may be curved in a plane containing the bore axis, while a cross-section of the bore defined in a plane perpendicular to the fore axis has one of (i) a curvature in a plane perpendicular to the bore axis, and (ii) a closed perimeter.
Embodiments also provide a set of devices configured to retain a dispenser of liquid, the set comprising: an active device and a passive device. Each of these active and passive devices includes: (i) a base with a top side and a bottom side, the base having first and second base ends; (ii) a holder body having first and second sides and an opening formed therethrough along a first axis from the first side to the second side, the opening being sized to retain the dispenser having a nozzle; and (iii) an arm elongated along a second axis that is inclined with respect to the first axis, the arm having a first end affixed to the holder body and a second end affixed to the base. Each of the active and passive devices is dimensioned such that (when the dispenser is retained in the opening with the nozzle directed along the first axis and away from the holder body) a target region for delivery of a drop of the liquid contained in the dispenser is defined in a first plane that is parallel to a plane passing through the first and second base ends, the target region being substantially centered at the first axis. In contradistinction with the passive device from the set, the active device additionally includes, at its arm, a data-recording unit containing an optical system with a field-of-view (FOV) defined to cover and include (a) a tip of the nozzle, when the dispenser is retained at the opening, and (b) the target region. Alternatively or in addition, and for every device in the set: the base may be arcuately shaped and dimensioned to fit above and in contact with a user's nose bridge; the device may be dimensioned such that, when the base is on a user's nose bridge, the first passes through an eye of the user when; and the opening may have a cross-section in a plane transverse to the first axis, the cross-section being one of (i) a rectangular cross-section and (ii) as a cross-section in which the opening defines a curve having a constant radius of curvature. Alternatively or in addition, at least one of a length of the arm and an inclination of the arm with respect to the base, in a device from the set, is adjustable to position the first axis to pass through a user's eye once the base is disposed on a user's nose bridge. In a particular embodiment, at least one device in the set includes a wing portion affixed to the arm at a point between the holding body and the base and extending from the arm along an axis that is transverse to a reference plane, the reference plane containing the first and second axes. In one embodiment, and for each device in the set, the base is curved in a plane containing the first axis and a cross-section of the opening defined in a plane perpendicular to the first axis has one of (i) a curvature in a plane perpendicular to the bore axis, and (ii) a closed perimeter. In a specific implementation of the set, a structural configuration of the active device and a structural configuration of the passive delivery device are substantially the same with an exception of the data-recording unit present at the arm of the active device. In a related embodiment, the active device may include one or more of (i) a programmable computer-readable processor in operable cooperation with tangible non-transient storage medium, the processor configured to acquire optical data that have been collected by the data-recording unit and that represent a scene at the target region; and (ii) a sensor system configured to wirelessly communicate with a programmable electronic circuitry to produce a record of time schedule of actual use of the active device, that has been equipped with the dispenser, for drop delivery into the target region. In one implementation, an optical axis of the optical system intersects the first axis at the target region and, optionally, it intersects the first axis at an acute angle (the acute angle being an internal angle of a triangle defined by the first axis, second axis, and optical axes). The holding body may be shaped as a cuboid. Alternatively or in addition, for each device in a set the bottom side is curved with a center of curvature located in a plane containing both the first and second axes, the center of curvature being separated from the first end by a distance exceeding a length of the arm.
A related embodiment provides a method for using a set of devices configured to retain a dispenser of liquid. The set of devices includes an active device and a passive device, wherein each of the active and passive devices contains (a) a base having a top side, a bottom side, and first and second base ends; (b) an arm extending from the top side of the base at a first end of the arm; (c) a holder portion with an opening therethrough, the opening having an opening axis and sized to retain a liquid drop container having a nozzle, (here, the holder portion is affixed to a second end of the arm such that when a corresponding device is in operational position with the liquid drop container retained at the opening, a target region for delivery of drops emitted from the nozzle is defined in a first plane that is parallel to a plane passing through the first and second base ends, the target region being substantially centered at the opening axis). In comparison with and in contradistinction to the passive device in a set, the active device additionally includes, at its arm, a data-recording unit containing 1) an optical system with a field-of-view (FOV) defined to cover and include (i) a tip of the nozzle of the container retained in the bore, (ii) the target region, and (iii) a space separating the tip from the target region, and 2) an optical detector. Here, the data-recording unit is configured to record images of a scene within the FOV. The method includes the steps of: applying hand input to the active device to emit a liquid drop from the container retained by the active device in a direction of the target region while recording a series of image frames, each frame representing a corresponding position of the drop in the space; monitoring, with the use of the data-recording unit, whether the drop landed in, partially in, or out of the target region; and using the passive device to deliver a liquid drop from the container retained therein to the target region. In one implementation, the use is made of a device (in the set) for which a third plane tangential to a point at the top side and the second plane are parallel to one another. The step of using may include i) applying hand input to the passive device to emit a liquid drop from the liquid drop container retained in by the passive device in the direction and/or ii) starting to use the passive device to deliver the liquid drop from the container retained therein when results of the monitoring indicate successful and repeatable delivery of the drop to the target region.
In a specific embodiment of the method, at least one of the following conditions is satisfied: (i) one or more of the applying, and using includes self-administering of the drop by the user without supervision; (ii) the monitoring includes wirelessly monitoring via a remote unit; and (iii) any of the applying and using includes compressing the liquid container, that has been retained at the opening, against a lateral protrusion located between the holder portion and the base with one of (a) a finger, and (b) a level portion of the device hingedly attached to the holder portion while the base is positioned on a nose bridge of a user with the bottom side in contact with the nose bridge, and wherein the target region is the user's eye. In one implementation, each of the applying and monitoring is carried out after the using. The method may additionally include one or more of the following steps: (i) adjusting one or more of a position of the active device, an orientation of the active device, and the hand input based on results of the monitoring; and (ii) inserting the liquid drop container in the opening of the holder portion to retain the container along the opening axis with the nozzle pointing towards the target region. The step of inserting may include one of the following: (i) retaining a flat tail portion of a single-use squeezable liquid drop container in said opening, the opening defining a hollow through the holder portion, the opening axis being completely surrounded by the holder portion in a cross-section that is transverse to the opening axis; and (ii) retaining a cylindrical neck of a multiple-use squeezable liquid drop container in said opening, wherein the opening is formed between first and second prongs of the holder portion, the first and second prongs extending transversely to the arm. In a specific implementation of the method, at least one of the top side and the art includes indicia of location, and any of the retaining the flat tail portion and retaining the cylindrical neck includes positioning a tip of the nozzle substantially at a level of said indicia of location. Alternatively or in addition, the embodiment of the method may comprise one or more of: (i) positioning any of the active and passive device on a nose bridge of a user while bringing a cross-stabilizer portion of the device in contact with a forehead of the user, wherein the cross-stabilizer portion extends transversely from the art between the holder portion and the base; and (ii) with a programmable electronic circuitry, generating a user-perceivable report containing data that represent whether the drop landed in, partially in, or out of the target region, and further complemented with determining if a change of employing the active device to employing the passive device is appropriate (based at least in part on a figure of merit calculated from said data and representing success of a drop delivery to the target region the report).
The invention will be more fully understood by referring to the following Detailed Description of Specific Embodiments in conjunction with the not-to scale Drawings, of which:
Relative scales of elements in Drawings may be set to be different from actual ones to appropriately facilitate simplicity, clarity, and understanding of the Drawings. For the same reason, not all elements present in one Drawing may necessarily be shown in another.
In accordance with preferred embodiments of the present invention, methods and apparatus are disclosed for solving the operational shortcomings of current devices and methodologies employed to aid in the delivery of a liquid drop to a region of interest (ROI). In particular, a shortcoming of current liquid drop-dispensing devices is their inability to conform to the specific needs of a particular user. This shortcoming is addressed by providing an operationally-adjustable device and a plurality of such devices, as a kit, that can be fit to a user's unique needs based on the user's anatomy (e.g., high nose bridge versus a low nose bridge) and/or any other physical traits of the user (e.g., tremors, arthritis, etc.), as well as the type of the used liquid container (e.g., single-use, multi-use, length, etc.).
Another shortcoming of current devices and methods employed to aid in the delivery of a liquid drop to a region of interest is the lack of means to evaluate and teach/train the user the correct way to effectively deliver a liquid drop to the ROI, specifically when the user is primarily attempting to deliver the drops in his/her at-home environment and without supervision. (Such situation is explained in detail in the accompanying Appendix, which provides the results of several clinical studies investigating this problem.) This shortcoming is addressed by providing two or more liquid drop delivery devices (configured to hold and retain liquid dispensers or drop dispensers such as containers of fluid), where at least one device is “active” (in that it has an event registration/feedback system such as an optical system or a sensor system, for example, configured to collect data and provide feedback about whether a drop is successfully delivered to the ROI or indicating whether and when the device is being used), and at least one other device is “passive” (in that, optionally being otherwise substantially structurally similar in configuration and operation to the “active” device, it does not have such a feedback system and is configured to simply hold, stabilize, and/or position a liquid-drop container to aid in successful delivery of the liquid drop(s).
An additional structural feature employed in an active device may be a feedback-generation capable system that is configured to monitor the process of delivery of the liquid drop, and/or to collect data regarding the user's delivery, or attempted delivery, of the drop to the ROI. The method for use of the array of devices includes operational transitioning between active and passive devices depending on the user's needs. If the user has not mastered the intended delivery technique, an active device can be used to monitor and track the drop delivery data. Depending on the feedback data, adjustments can be made to the user's delivery technique. For example, once the actively collected data indicate that drop delivery is successfully occurring as intended (either spatially, with respect to the targeted ROI, or temporally, in terms of the delivery on schedule, or both), the user can transition to using a passive device. Accordingly, the process of using the platform or set or kit of devices includes a user's transitioning from employing the active device to employing the passive device (once the data collected by the feedback system indicate that the user's drop-delivery-to-the-ROI technique is successful). In a related example, if the user has other specific needs (for example, they user forgets to deliver the liquid at the appropriate times), an active device used at the time can be additionally equipped with a sensor system that can be paired with a smartphone or other wireless application, which is programmed to remind the user to use the liquid drops if and/or when the device is not used at the appropriate times. Alternatively, the process of using the set may include the user's transitioning from employing the passive device to employing the active device (once the collection of feedback data is prompted by lack of success of using the “passive” device on the user's part, to begin with).
Yet another shortcoming of current devices is the problem caused by the inability of existing liquid-drop-delivery aids and monitoring systems to accommodate single-use containers and/or dispensers of liquid (to which related industry is transitioning) This deficiency is solved by providing an embodiment of a device configured to contain a cavity, judiciously sized to retain a single-use liquid drop dispenser, while the device also has an optional built-in feedback system (such as an optical means for continued monitoring of the liquid drop delivery to the ROI or a sensor system for indicating whether and when the device is being used).
While various Figures discussed below show specific embodiments of either a passive device or an active device, it is appreciated that all embodiments of the invention generally have in common several structural components and/or characteristics, regardless of a particular configuration, orientation, and/or dimensions of such components. Preferably, all embodiment are made from material(s) lending themselves to injection molding, lathe machining, or 3D printing. Such common components are now introduced in reference to
The arm 120 extends from the top side 130 of the base 115 and connects at its other end to the holder 125. The holder 125 includes a body 140, which has a first surface 145 and a second surface 150 (as shown—upper and lower surfaces of the body 140), and a bore or cavity or hole or recess or space 155 that is formed through the body 140 and extends from the first surface 145 to the second surface 150 along a bore/cavity/hole/recess/space axis 160.
Generally, the bore 155 can be fully closed on four sides that circumscribe/surround the first axis 160, as shown in embodiment 100 of
When the devices are in their operational position, the holder 125 is oriented above the base 115 and the region of interest (ROI) 170 is located substantially below the bore 155 (and, optionally, in a plane that is parallel to the plane passing through the ends 115A, 115B).
The arm 120 is affixed to the body 140 at the arm's first end and extends from the body 140 generally along a second axis 175 that is inclined with respect to the first axis 160. The arm 120 has its other end affixed to the base 115. When the base 115 has an arcuate shape, the center of curvature of the arc may be chosen to lie in a plane that contains both the first axis 160 and the second axis 175, and such that the center of curvature is separated from the first end of the arm 120 by a distance exceeding a length of the arm 120. In one implementation, where the base 115 is chosen to be shaped as substantially half-an-ellipse (with 16 mm minor axis and 20 mm major axis, or, alternatively, a half round with a 20 mm diameter; with the thickness of the body of the base 115 is about 2.8 mm, while the width is about 10 mm) the distance between the axis 160 and the center of the base (nose bridge) 115 is 31 mm, resulting in that the center of region of interest 170 is at a separation distance of about 31 mm away from the center of the nose bridge during the operation of the device, to address a typical distance between eye-pupils of a typical person of about 58 mm to about 66 mm. This separation distance can be customized for patients.
These general structural features are judiciously chosen to ensure that both the active and the passive versions of a particular embodiment are substantially structurally similar to one another, and can be used interchangeably by the same user with minimal—if any—deviation from the established drop-delivery procedure to which the user became accustomed while using one of the versions of such device.
Example 1: Drop-Dispenser for Single-Use Container. Referring now to
Additionally, the single use container device may contain a marking or reference element 122 (such as a protrusion or indentation or another indicia of location on a surface of the arm 120) configured to indicate a level or a point with respect to which (for example, above which) the tip of nozzle 285 of the single-use container 280, after opening, should be placed for use in a particular application (In a non-limiting and a very specific example, in an application of a drop to the eye, such marking element serves to reduce risk of contact of the container 280 with the eye).
Example 2: Drop-Dispenser for Single-Use Container. According to the idea of the invention, various embodiments of passive devices are tailored to specific needs of a user of the device(s). For example, the embodiment 900 shown in
The foot or base 115 is shown equipped with a shelf or protrusion 935 (which, in the alternative implementation can also be formatted as an indentation or another indicia on a surface of the foot or base 115), and configured to indicate a level or a point with respect to which (for example, above which) the tip of nozzle 285 of the single-use container 280, after opening, should be placed for use in a particular application (in a non-limiting and a very specific example, in an application of a drop to the eye, such marking element serves to reduce risk of contact of the container 280 with the eye). In other words, the element 935 is configured to assist with proper positioning of the drop bottle tip when such bottle is retained in the embodiment of the drop dispenser.
Example 3: Drop-Dispenser for Single-Use Container. The embodiment 1100 shown in
The tongues 1110 aid in causing a single-use container 280 (once inserted and retained in the bore 1120) to emit the desired amount of fluid (for example, a pre-determined number of drops) when squeezed or pressed against the tongues 1110. The multiplicity of tongues 1110—as opposed to a single, only tongue—allows, in operation of the device with different single-use containers, for compression of differently-shaped single-use containers (the outer surface of some of which may be concave, as that in
Example 4: Drop-Dispenser for Single-Use Container. The embodiment 1200, shown in
Example 5: Single-Use Containers of Fluid. Referring to
Example 6: Drop Dispenser for Multi-Use Container. Referring to
Example 7: Multi-Use Containers. Referring to
Example 8: Drop Dispenser for Multi-Use Container. Referring to
Example 9: Drop Dispenser for Multi-Use Container.
The shape, dimensions, angular orientation—generally, configuration - of the cross stabilizers in relation to that of the arm 120 may be arranged in various formats, including, but not limited, to having only one cross stabilizer (that is, a cross stabilizer on only one side of the arm 120). It should also be noted that, generally, any of related embodiments disclosed herein—where active, passive, or configured for use with a single-used container(s) of liquid—may be equipped with at least one of the cross stabilizers 1305A, 1305B.
The idea behind complementing an array or kit or set of passive fluid-dispenser holders with embodiments of active devices is to enable a user of the kit to at least train himself to deliver drops of fluid into his eye(s) based on operational feedback provided by the active device in terms of optical data representing circumstances of drop(s) delivery (such as timing, success of delivery). Alternatively or in addition, the optical data collected with the active device in an unbiased fashion (and without human interference) can be used by the observing clinician for the purposes of adjusting the type of treatment to be used (for example drops versus laser or surgery for glaucoma) or the addition or subtraction of a drop medication to the patient's treatment regimen or at least one of the dose and schedule of patient's (user's) treatment, in an exact and systematic fashion to answer questions relevant to the success of the patient's treatment and evaluation of outcomes of such treatment.
Example 10: Drop Dispenser for Single-Use Container. To this end, and referring to
Example 11: Drop Dispenser for Single-Use Container.
Depending on the specifics of use, each previously described embodiment of a passive device may be appropriately modified to be transformed into or formatted as an active device. For example, referring to
Generally, the active unit of a given embodiment (such as the active units 705, 805) and an optical system 705A, 805A of such unit can be configured substantially equivalently for both an active device structured to accommodate single-use containers of liquid and an active device structured to accommodate multi-use containers of liquid. In related embodiments, the active units can be connected, via electrically-conducting members or otherwise, to a local or remote programmable processor, which is in operable cooperation with tangible non-transient storage medium. The processor in such case is configured to acquire optical data collected by the optical system 705 representing an image of a scene present at a given time at the ROI 170. These data can then be analyzed to determine if a liquid drop expelled from the nozzle (285 of the single-use container, or 460 of the multi-use container, affixed in the body 140 is successfully delivered to the ROI 170).
Alternatively or in addition, the optical system 705A, 805A could be augmented with a sensor system that contains a communications function. This sensor system could be disposed in a housing of the active unit 705, 805 and/or paired with a computer-based application to perform various functions. This computer-based application could, for example, be downloaded onto a smartphone or similar device. The sensor system could communicate with the application to indicate at which times the active device is being employed. If the active device is not being employed according to the specified scheduled, the application would alert the user via their smartphone to use the device to administer the missed drops after a scheduled administration is not sensed.
If a particular user's specific needs so demand, each of the embodiments described herein may be structurally adjusted to fit such specific needs. This adjustability may be embodied in the device itself (for example, at least one of the length of the arm 120 and the angle of the arm 120 with respect the foot or base 115, may be adjustable, via an appropriate telescopic mechanism and/or hinge)
Alternatively, or additionally, the customization of a specific embodiment may be achieved by fitting differently-sized devices to the particular user to determine which suits the needs of the user most effectively. Such fitting could be performed in a number of different ways, for example, it could be accomplished through input of the parameters of a particular liquid container being used into a database (which, with the use of a programmable processor would match the container, based on its dimension, to the most appropriate embodiment of the device). The fitting could also be done by office personnel and could involve the user trying different devices to determine which one works best for the user's particular needs. The process of fitting could also involve measuring the facial feature (such as the height of the bridge of the nose) of the user, and selecting the device based at least in part on the results of such measurement. Various device embodiments are optionally sizable, meaning that their dimensions can be individualized and that they are designed to pursue the variability of different lengths of liquid container tips, and/or distance of the tip to the ROI, and/or the anatomy of the user, and/or problems individual to a user (e.g., tremor, stiff neck and cannot lean back, keeps touching eye and needs offset from eye, or closes eye and drop lands on upper lid or lower lid).
The use of either of an active device of the invention or a passive device of the invention, or a set of such devices is intended to include at least some of the following steps: using the active device with a liquid-containing capsule affixed in a bore/opening thereof to deliver a series of liquid drops; monitoring a data set representing a delivery of the series of liquid drops supplied by the active device with the capsule in it; making adjustments to a user's delivery technique based on assessment of the data set; and initiating a use of a passive device with a liquid-containing capsule affixed in a bore thereof to deliver liquid drops when the data set indicates that the user's delivery technique is successful in delivering liquid drops to a region of interest as intended. The “intent” of delivery, determining its success, may include successful targeting of the ROI with a liquid drop and/or targeted delivery of such drop according to a pre-determined schedule. While this example of a method of use of a set of devices illustrates a progression from using an active device to using a passive device, it should be noted that the progression of use of the system of devices could be from use of a passive device to that of an active device. As an example, a user may be initially using a passive device, but unsuccessfully in that the user fails to administer the drops as intended, in which case the user may be directed to use an active device with a sensor, feedback capable system for active monitoring of drop delivery and/or reporting of the results of such monitoring. In this specific example, the collection of feedback data is prompted by lack of success of using the “passive” device on the user's part.
In some users that start with the passive device and do not experience difficulties with delivery and compliance, it may not be necessary for them to use an active device and the passive device may suffice.
The active monitoring device can also be used to assist drop delivery and determine if a drops is being used successfully. If delivery is not successful, even with the assist device, it may be determined that adding additional drops would not help since they are not getting into the eye not because they are not working. This information can then be used to try and train the individual on proper drop use and not to add more drops. It can also lead to the determination that an alternative treatment methods, say laser or surgery for glaucoma patients is preferred to additional drops. For physicians and insurance companies, this can reduce waste, and insure that the treatment is individually targeted to the patient based on the patients individual needs to result in better outcomes and less waste.
The active device has been described as including a processor controlled by instructions stored in a memory. The memory may be random access memory (RAM), read-only memory (ROM), flash memory or any other memory, or combination thereof, suitable for storing control software or other instructions and data. Those skilled in the art should readily appreciate that instructions or programs defining the functions of the present invention may be delivered to a processor in many forms, including, but not limited to, information permanently stored on non-writable storage media (e.g. read-only memory devices within a computer, such as ROM, or devices readable by a computer I/O attachment, such as CD-ROM or DVD disks), information alterably stored on writable storage media (e.g. floppy disks, removable flash memory and hard drives) or information conveyed to a computer through communication media, including wired or wireless computer networks. In addition, while a portion of the invention may be embodied in software, the functions necessary to implement the invention may optionally or alternatively be embodied in part or in whole using firmware and/or hardware components, such as combinatorial logic, Application Specific Integrated Circuits (ASICs), Field-Programmable Gate Arrays (FPGAs) or other hardware or some combination of hardware, software and/or firmware components.
While the invention is described through the above-described exemplary embodiments, it will be understood by those of ordinary skill in the art that modifications to, and variations of, the illustrated embodiments may be made without departing from the inventive concepts disclosed herein. For example, although some of the embodiments are described in connection with various illustrative structures, one skilled in the art will recognize that the system may be embodied using a variety of different structures. Examples of related embodiments of individual devices are illustrated in Appendix A. Modifications of embodiments may include an added contraption configured to compress the bottle automatically or electronically to improve drops delivery, or which is only activated to deliver the drops when the device is placed in the correct position. Modifications may further include, for specific embodiments configured to be used with a ROI that includes an eye of the user, different structures of the arm or arm of a device, a light source added to the optical system and having an illumination zone that includes a tip of the single use liquid drop dispenser and the eye of the user located below the rectangular cavity when the arcuate base of the first end is positioned above the user's nose root; and/or a compressor unit configured to compress a liquid holding container against a side of the arm; and/or a sensor system to communicate with a computer-based application to indicate at which times the liquid drop delivery device is being employed; and/or a the computer code governing the processor to generate data to inform the user that a scheduled drop was missed.
The scope of the invention includes, for example, a set of devices configured to retain a dispenser of liquid, where the set includes a first device having (a) a base with a top side and a bottom side, the base having first and second base ends; (b) an arm extending from the top side of the base along a first axis and attached to the base at a first end of the arm at a point that is separated from a first plane passing through the first and second base ends; and (c) a holder portion with an opening formed therethrough, the opening having a second axis that is inclined with respect to the first axis, a cross-section of the opening in a second plane that is transverse to the second axis being one of (i) a cross-section containing a right angle, and (ii) as a cross-section in which the opening defines a curve (in a specific case - a curve having a constant radius of curvature). Such set may additionally include a unit containing an optical system with a field-of-view, the unit being cooperated with the arm to orient the FOV to cover a tip of a nozzle of the dispenser when the dispenser is retained in the opening and oriented with the tip pointing towards the first plane. In one embodiment, the set is configured to meet at least one of the following conditions: (i) the base is arcuately shaped and dimensioned to fit above and in contact with a user's nose bridge; (ii) the base is curved in a plane that contains the second axis, while a cross-section of the opening defined in a plane perpendicular to the second axis has one of (a) a curvature in a plane perpendicular to the bore axis, and (b) a closed perimeter; (iii) at least one of a length of the arm and an inclination of the arm with respect to the base is adjustable; (iv) the first device further includes a wing portion affixed to the arm at a point between holding portion and the base and extending from the arm along an axis that is transverse to a reference plane, the reference plane containing the bore axis and passing through the arm; and (v) the first device further includes a platform, repositionably disposed substantially parallel to a cross-section of the opening, and a return mechanism configured to apply a bias force to the platform in a direction of the opening The first device in the set may additionally contain an extension, protruding from the holder portion towards the first plane to form a gap between the arm and the extension, (the gap configured to accept a first finger of a user when the dispenser is retained in the opening and, while a second finger of the user is in contact with a surface of the dispenser, to allow to squeeze the dispenser between the extension and the second finger). The extension may carry at least one tongue protruding from the extension on a surface facing away from the gap, and wherein the cross-section of the opening is a rectangular cross-section dimensioned to retain a tail portion of a single-use dispenser filled with eye drops. The set may include a second device configured substantially equivalently to the first device, wherein dimensions of at least one component of the second device appropriately differ from those of a corresponding component of the first device to accommodate different physical characteristics of a user choosing a device from the set (i) to retain the dispenser in the opening and position the base on a bridge of a nose of the user with a tip of a nozzle of the dispenser being separated from an eye of the user by about 10 mm, and (ii) to successfully deliver a drop of the liquid from the nozzle to a surface of an eye while the device is so positioned.
The scope of the invention also covers a system configured to retain a dispenser of liquid, where the system contains a holder portion with an opening configured to retain and fixatedly support the dispenser of liquid, the dispenser having a nozzle, and a body extension that is attached to and stretches forth from the holder portion and that is configured, in operation, to contact a user to support the dispenser at a separation distance from the user. The dimensions of various components of the system can vary (while generally retaining their structural characteristics) to accommodate differences in anatomies of users of the system and dispensers of different lengths. In a specific case, the system may include a first device that has such body extension, and in which case the body extension contains a base with a top side and a bottom side, the base having first and second base ends, and an arm extending from the top side of the base along a first axis and attached to the base at a first end of the arm at a point that is separated from a first plane passing through the first and second base ends. The first device also includes the above-described holder portion with an opening formed therethrough, the opening having a second axis that is inclined with respect to the first axis, a cross-section of the opening in a second plane that is transverse to the second axis being one of (i) a cross-section containing a right angle, and (ii) as a cross-section in which the opening defines a curve. IN a related embodiment, the system additionally comprises a second device that is substantially structurally equivalent to the first device and that, in addition, contains at its arm, a data-recording unit containing an optical system with a FOV defined to cover and include a tip of the nozzle when the dispenser is retained at the opening
One non-limiting modification includes a composite implementation 2300 of the active device shown in
Accordingly, the invention should not be viewed as being limited to the disclosed embodiment(s).
Here, the results of one of several empirical studies are summarized to highlight the unmet need(s) related to the use of liquid drop dispensers (such as lack of ability to evaluate and trains the user to correctly and efficiently deliver a liquid drop from the dispenser to the ROI when the currently-used in the related art devices and methods for such delivery are being used in at-home environment and /or without supervision) and satisfaction of such needs with the use of an embodiment of the invention.
It is well recognized that while patient adherence to a prescribed ophthalmic regimen is problematic yet data assessing eye drop instillation outside of the clinic is limited.
Cataracts affect approximately 17% of Americans 40 or older and this number increases to more than 65% by age 80. Consequently, cataract surgery is one of the most frequently performed outpatient procedures in medicine, with over 3 million procedures per year in the USA alone. After the surgery, physicians typically prescribe antibiotic eye drops to prevent infection and anti-inflammatory eye drops to help reduce inflammation and speed visual recovery. Failure to adhere to the post-surgical eye drop regimen can lead to complications such as severe inflammatory reactions, macular edema, and endophthalmitis which can cause vision loss and intraocular scarring. Additionally, improper delivery (for example, with the tip contacting and pressing on the cornea) can result in wound distortion and intraocular infections. Another significant issue with eye drops that is consistently reported by physicians and patients is problems with drop adherence. Studies have shown that over 90% of patients may not be using their eye drop medications correctly, though only 31% of patients report having difficulty instilling their eyedrops. Not only does incorrect dosing have the potential to impair the visual recovery process following the surgery and increase the risk of inflammation and/or infection, but incorrect perceived or actual deviations from the prescribed regimen can also restrict a physician's ability to determine the optimal therapeutic regimen. Furthermore, cases of poor drop-delivery techniques, which require additional drop applications to be compensated, can drive up health costs if an early refill of the liquid medication is needed.
The purpose of this study was to directly assess at-home patient adherence with prescribed eye drops in post-cataract surgery patients. Poor adherence, whether intentional or unintentional, is most likely due to the discrepancy between perceived versus actual administration of eye drops where subjects believe they are performing better than what is actually occurring. Thus we hypothesize that the perceived drops dispensed and drops landing in the eye will be significantly different from both the actual dosing and the prescribed regimen.
Inclusion/exclusion criteria: An observational case study was conducted at a single site with twenty--seven post-cataract surgery patients (age 58-92; mean age 71) taking prescription eye drops. Only those who could self-consent were enrolled in the study. All patients reported their drop usage in a daily log and used an embodiment of an active (imaging) device to record their prescribed eye drop administration for one week. Video data from the recording device were further processed.
The average number of time points recorded per patient was 33±3 (range 25-42). In total, 881 videos were recorded and analyzed. All subjects in the trial signed informed consent forms and Institutional Review Board approval for this study was obtained from the Lee Memorial Health System. It is certified that all compliance requirements were adhered to and all applicable institutional and governmental regulations concerning the ethical use of human volunteers were followed during this research.
Study Design: This was a non-randomized prospective pilot study. Twenty-seven participants were instructed on use of an embodiment of the novel imaging device, referred to herein as EDAM. The active device, the embodiment of which was discussed in U.S. patent application Ser. No. 14/438,716 (and is incorporated herein by reference in its entirety), is shown in frame A of
Statistical Analysis: The number of drops dispensed, drops in, and drops half in and half out were compared between the subject (perceived), the reading center (actual), and the prescribed regimen. Particularly the actual treatment (drops in/prescribed), intention to treat (drops dispensed/prescribed regimen), and success rate (drops in/drops dispensed) were calculated and converted to percentages. Percentages were used because the prescribed regimen varied slightly between patients depending on the time of enrollment i.e. patients enrolled in the afternoon so any drops administered prior were excluded from the prescribed regimen. Percent absolute variations were calculated by subtracting each value from 100% and converting each difference into the absolute value. By comparing absolute variations, the deviation from the prescribed regimen is better visualized as overall means may misrepresent adherence rates since upper and lower values negate each other. Paired t-tests were used to assess significance in all analyses (GraphPad Prism 4). A power analysis to determine sample size was not completed. Further, the small sample size did not allow for the assessment of covariates such as age, sex, or education on drop delivery in this pilot study. Values given are mean and standard deviation.
Patients who underwent cataract surgery from a single private practice were enrolled in a study in which their eye drop administrations were monitored using the EDAM device. Thirty-two subjects were enrolled; however, five subjects opted out of the study after enrollment. Twenty-seven patients completed the study and their demographic information is provided in Table of
Subjects' perception (Perceived) of their drop administration was determined from the supplied log they filled out during the study period and compared to the videos captured on the EDAM device (Actual). Examples of images recorded are shown in frames B, C, and D of
Comparing the intention to treat (
The number of missed events (i.e. no video for a particular time point and presumably no drops dispensed) and the number of times the dropper tip came in contact with the cornea, eyelashes, or skin were noted during video analysis (see Table of
This study is the first to directly measure adherence with postoperative medications following cataract surgery while at patients' homes. Overall, our results are consistent with previous findings that patient reports of eye drop regimen adherence are significantly different from their actual adherence. In the early 1980s, Kass et al interviewed 141 patients on their eye drop adherence and then observed their administration. They reported that 83% of patients instilled one drop per application yet during observation over 48% dispensed two or more drops. Similarly, Stone et al questioned 139 patients on their topical medication usage and subsequently video recorded their eye drop instillation using two different bottles. They reported that over 90% of patients believe they do not have difficulty putting in their drops; however, less than 31% of patients administered a single drop without contaminating the drop tip. In our observations, we report similar discrepancies between what patients perceive compared to what is recorded on the EDAM. For instance, patients reported that they applied the correct number of drops and only deviated from the prescribed regimen by 5% but in reality they deviated by almost 24%. Comparing the intention to treat yielded similar results where patients believed they are dispensing the appropriate amount but after video analysis it is disclosed in FIG. 3B that they varied from the prescribed regimen by almost 30%. Further, 5 (18.5%) subjects over-dispensed their drops by greater than 30% making them at risk of running out of their medication prior to the end of their prescribed regimen. While it is clear that some patients are having difficulties instilling their ophthalmic drops, this is not the case for every patient. For example, twelve (44.4%) of the twenty-seven patients had an adherence rate of at least 80% or higher with regard to actual treatment, intention to treat, and success rate. Therefore, to improve overall drop delivery and compliance, it is critical to identify those patients who are having problems to allow for retraining or utilization of alternative postoperative drug delivery options.
Topical antibiotic, steroid, and nonsteroidal eye drops are commonly prescribed following cataract surgery, but if a patient is non-adherent or incorrectly applies them in a way that disrupts or opens the incision they may increase their risk of post-operative infection(s). Endophthalmitis following cataract surgery is a rare (approximately 1 in 800 cases) but serious occurrence which can result in vision loss. Failure to achieve prescribed antibiotic, steroidal, and non-steroidal eye drops delivery to the eye can increase the risk of inflammation, pain, scarring, and cystoid macular edema which can delay and/or impair visual recovery. Unwanted contact with the lids and cornea can cause irritation, wound gape, and potentially increase the risk of infection and other problems. Our data indicates that drop delivery is a significant problem following cataract surgery. How best to manage this risk has yet to be determined. Attempts have been made to address issues associated with drop delivery and non-adherence, including phone apps, automated voice and text alerts, retraining, physical devices for assisting with drop placement and bottle squeezing, and altering the color and/or shape of the dropper bottle to increase usability.
It has long been known that variation in drop dispensing and delivery with the prescribed eye drop regimens is an issue; however, the depth of the problem has never been directly determined at home following cataract surgery. The results of the above-presented study indicate that lack of eye drop delivery is a ubiquitous problem and affects anyone prescribed ophthalmic drops, although it does affect some more than others. When this is compounded with general problems of adherence (where forgetfulness is the most commonly cited issue, resulting in missing a drop administration), it is easy to appreciate the combined significance of both of these problems to the delivery of health care to patients. Currently, physicians must evaluate the state of the disease of their patients and the effect the prescribed regimen based on a patients presentation and self-reported (or perceived), adherence rather than the actual objective data. While assumptions about therapeutic effects are not ideal, the assumptions have been the only option up to-date because direct, objective data have not been available. Through the use of the embodiment of the invention (EDAM), a significant discrepancy between perceived and actual drop dispensing and delivery, by the patient's themselves and without supervision. The results highlight the necessity of collecting accurate data of not only adherence but of eye drop applications from patients outside of the clinical environment. Such information is especially pertinent for physicians to better understand and positively affect clinical outcomes for each and every patient or for those interested in ensuring proper delivery of topical medications.
The present application claims priority from and benefit of US Design Patent Application No. 29/615,056 filed on Aug. 25 2017; US Design Patent Application No. 29/611,244 filed on Jul. 19, 2017; US Provisional Patent Application No. 62/415,384 filed on Oct. 31, 2016, and US Provisional Patent Application No. 62/383,231 filed on Sep. 2, 2016. The disclosure of each of the above-identified patent applications is incorporated by reference herein.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2017/048819 | 8/28/2017 | WO | 00 |
| Number | Date | Country | |
|---|---|---|---|
| 62415384 | Oct 2016 | US | |
| 62383231 | Sep 2016 | US |
